Written Exposure Therapy for Veterans With SUD and PTSD

Posttraumatic Stress Disorder Clinical Trial

— WET  

Official title:

Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327504
• Other study ID #: MHBP-010-21F
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Michael Merritt
• Phone: (352) 548-6000
• Email: michael.merritt[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

Description:

This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 30, 2027
• Est. primary completion date: May 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veterans ages 18 years old or older;
• Meets DSM-5 criteria for at least one substance use disorder (SUD);
• Meets DSM-5 criteria for PTSD;
• Approved for SUD treatment at VA Connecticut Healthcare System.

Exclusion Criteria:

• Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
• current suicidal or homicidal risks necessitating a higher level of care;
• Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
• Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Written Exposure Therapy
Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.
• Neutral Topic Writing
Treatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist for DSM-5 (PCL-5)	PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.	8-week Post-Baseline Follow-up
Primary	PTSD Checklist for DSM-5 (PCL-5)	PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.	12-week Post-Baseline Follow-up
Secondary	Timeline Follow-Back (TLFB)	Timeline Follow-Back (TLFB) will be provided at baseline, and at post-treatment (after 5 writing sessions), 8-week, and 12-week post-baseline follow-up. Calendar-based interviews using the Timeline Follow-Back (TLFB) method will document the frequency of drug and alcohol use for the 3 months prior to baseline assessment, and during the writing sessions (taken at post-treatment follow-up), 8-week, and 12-week post-baseline follow-up. Following baseline, the TLFB will capture days since last assessment (e.g., days between baseline and post-treatment, post-treatment, and 8-weeks, and 8- to 12-week follow-up). Higher numbers of days of use will equal higher substance use.	8-week Post-Baseline Follow-up